Scientist - Study Director Toxicology

at  Labstat International Inc

Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
We are currently looking for a Scientist – Study Director to join our growing team in Kitchener with our Labstat Division!

MINIMUM QUALIFICATIONS:

• M.Sc or PhD in Toxicology, Biology or Cellular Biology or related field
• Three (3) or more years experience in a lab testing environment
• Experience in nonclinical toxicology
• Experience with in vitro assays
• Experience with flow cytometry
• Ability to work under strict deadlines in a fast-paced environment
• A team player while still having a strong drive to push forward
• Working knowledge of Good Laboratory Practices (GLP) regulations

THE SCIENTISTS IS RESPONSIBLE FOR THE ANALYTICAL ACTIVITIES WITHIN THE LABORATORY. THIS INCLUDES:

• Overseeing assay performance and addressing assay deviations from set performance indicators
• Responsible for life cycle management of assays
• Method evaluation/validation and troubleshooting
• Maintain and update relevant SOPs
• Maintain assay precision, accuracy, and reproducibility through appropriate QC procedures
• Lead RCA for deviations and repeats
• Effectively communicate and coach the operations team
• Contribute to the implementation of new Toxicology assays as needed
• Interact with clients on technical issues
• Process analytical data

PRIMARY RESPONSIBILITIES OF THE JOB:

• Act as a subject matter expert for the various nonclinical assays
• Oversee the day-to-day assay performance and ensure that any deviations are corrected in a timely manner
• Successfully implement/validate and troubleshoot new HTP methods
• Ensure that the scientific quality of the assay’s is not compromised during production
• Follow QC procedures including QC charting and related measures related to Statistical Process Control (SPC)
• Maintain assay precision, accuracy, and reproducibility through appropriate QC procedures.
• Interact, supervise, and communicate effectively with peers
• Work with the operations team to determine the required timelines for specific projects/analyses/method development.
• Process analytical data and liaise with internal statistical department
• Communicate analytical results to relevant stakeholders
• Discuss technical inquiries with clients in a manner which is in keeping with company policy.
• Lead RCA investigations and ensure that resolutions are identified in a timely manner
• Perform duties of the Study Director for GLP Studies. Specifically, but limited to:
• Ensure that the scientific, administrative, and regulatory aspects of the GLP study are controlled by coordinating the inputs from management, scientific/technical staff and the Quality Assurance program (QS).
• Oversee the study plan design and approval, including any amendments, as well as overseeing data collection, analysis and reporting.
• Prepare Study Plans/Study Protocols in consultation with the sponsor (client) and internal Management
  Other duties as assigned